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Realmada Therapeutics
NEWS

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Shots: Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…
April 29, 2025

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Merck
NEWS

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Shots: The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025) At 38.3 mos. mFU,…
April 28, 2025

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Vivavision Biotech
NEWS

VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

Shots: VivaVision has reported topline P-II trial data assessing 1.0% or 0.5% VVN461 (JAK1/TYK2 inhibitor) vs 1% prednisolone acetate (PA) for the treatment of non-infectious anterior uveitis in 86 Chinese pts for 28 days Trial demonstrated non-inferior efficacy to PA, achieving a 2-step ACC grade reduction (measured via SUN scale) as the 1EP & significant improvements…
April 25, 2025

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Gilead
NEWS

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Shots: The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Trial showed improved PFS (1EP); OS (2EP) was immature but showed…
April 22, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157) Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…
April 21, 2025

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Briacell
NEWS

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…
April 17, 2025

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